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Canadian e-Platform to Promote Behavioral Self-Management in Chronic Heart Failure: CHF-CePPORT (CHF-CePPORT)

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ClinicalTrials.gov Identifier: NCT01864369
Recruitment Status : Unknown
Verified October 2017 by Robert Nolan, University Health Network, Toronto.
Recruitment status was:  Active, not recruiting
First Posted : May 29, 2013
Last Update Posted : October 26, 2017
Sponsor:
Collaborator:
Heart and Stroke Foundation of Ontario
Information provided by (Responsible Party):
Robert Nolan, University Health Network, Toronto

Brief Summary:

Chronic Heart Failure (CHF) is a growing public health issue in Canada. Hospital re-admission within 1-year after diagnosis is 25-40%, and the 5-year rate of CHF death is 50%. Counseling by multidisciplinary health care teams helps CHF patients to improve self-care behaviors (for medications, diet, exercise, smoking cessation and symptom monitoring), and this reduces the rate of death and CHF hospitalization. In the absence of intervention, patient adherence to these behaviors is below recommended standards and quality of life among CHF patients becomes progressively compromised. A major challenge is to make self-care counseling available without overtaxing health care resources.

This 3.5 year multicenter clinical trial will establish and evaluate a Canadian e-platform that provides multidisciplinary e-counseling to help patients with CHF to initiate and maintain recommended self-care behaviors. The investigators will recruit 298 CHF patients in Toronto, Montreal and Vancouver. The investigators hypothesize that a 12-month program of e-Counseling + Usual Care versus general eInfo + Usual Care will improve quality of life, self-care behaviors and heart health. This proposal is based upon previous clinical trials in CHF, e-health and preventive lifestyle counseling by our team. It also builds upon our established collaboration with the consumer eHealth program of the Heart and Stroke Foundation of Ontario. The novel contribution of this research is that it will establish an infrastructure for a pan-Canadian e-platform in preventive e-counseling for CHF. A key feature of this proposal is that our multidisciplinary team will work with the Heart and Stroke Foundation to share our findings and e-health resources with the public and other health care professionals in Canada, which will help to galvanize research and clinical work in eCounseling. Our clinical trial will strengthen eCounseling services in order to improve the quality of life of patients with CHF.


Condition or disease Intervention/treatment Phase
Heart Failure Behavioral: eCounseling + Usual Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 248 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Canadian e-Platform to Promote Behavioral Self-Management in Chronic Heart Failure: CHF-CePPORT
Study Start Date : September 2013
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Active Comparator: Control: eInfo + Usual Care
Usual Care + eInfo on general guidelines for heart healthy living
Behavioral: eCounseling + Usual Care
This intervention will use film vignettes and interactive web pages. The e-counseling messages will promote: (i) validation of the subject's stage of "readiness" for behavior change, (ii) collaborative participation by means of subject-selected menus, (iii) reinforcement of "change talk" to resolve ambivalence, (iv) use of self-help information and e-tools for self-monitoring of targeted self-care behaviors, and (v) development of cognitive-behavioral skills to build and strengthen efficacy. Messages will be proactively sent to Controls according to the following schedule: weekly for months 1 to 4, bi-weekly for months 5 to 8, and monthly for months 9 to 12.

Experimental: Behavioral: eCounseling + Usual Care
Behavioral:eCounseling + Usual Care: interactive web pages utilized to provide e-counseling messages and e-tools.
Behavioral: eCounseling + Usual Care
This intervention will use film vignettes and interactive web pages. The e-counseling messages will promote: (i) validation of the subject's stage of "readiness" for behavior change, (ii) collaborative participation by means of subject-selected menus, (iii) reinforcement of "change talk" to resolve ambivalence, (iv) use of self-help information and e-tools for self-monitoring of targeted self-care behaviors, and (v) development of cognitive-behavioral skills to build and strengthen efficacy. Messages will be proactively sent to Controls according to the following schedule: weekly for months 1 to 4, bi-weekly for months 5 to 8, and monthly for months 9 to 12.




Primary Outcome Measures :
  1. Quality of Life [ Time Frame: 12 months ]
    The primary outcome in CHF-CePPORT is quality of life, as measured by the number of subjects who demonstrate a clinically meaningful increase of ≥5 points on the summary index of the Kansas City Cardiomyopathy Questionnaire (KCCQ).


Secondary Outcome Measures :
  1. Behavioral,functional and clinical outcomes [ Time Frame: 4- and 12- months ]
    Quality of life: number of subjects with KCCQ ≥5 points

  2. Behavioral, clinical and funcitonal outcomes [ Time Frame: 4 and 12- months ]
    Adherence to daily dietary guidelines for fruit and vegetable intake: NIH/NCI Diet History Questionnaire.

  3. Behavioral, functional and clinical outcomes [ Time Frame: 4- and 12- months ]
    Physical activity: 4-day step count with Triaxial Accelerometer.

  4. Behavioral, functional and clinical outcomes [ Time Frame: 4- and 12- months ]
    Self-reported daily activity: The Physical Activity Scale for the Elderly.

  5. Behavioral, functional and clinical outcomes [ Time Frame: 4- and 12- months ]
    Smoking-free living: Cotinine (only subjects identified as smokers at baseline)

  6. Behavioral, functional and clinical outcomes [ Time Frame: 4- and 12- months ]
    Medication adherence: Medication Possession Ratio over 4 months.

  7. Behavioral, functional and clinical outcomes [ Time Frame: 4- and 12- months ]
    Psychological adjustment: Patient Health Questionnaire - 9-item scale (Depression)

  8. Clinical and functional assesments [ Time Frame: 12-months ]
    The Seattle Heart Failure Model.

  9. Clinical and functional assesments. [ Time Frame: 12-months ]
    Functional capacity: 6-minute walk test.

  10. Behavioral, functional and clinical outcomes [ Time Frame: 4- and 12- months ]
    Generalized Anxiety Disorder - 7-item scale (Anxiety).


Other Outcome Measures:
  1. Clinical variables [ Time Frame: 12-months ]
    NT-proBNP (as available).

  2. Clinical variables [ Time Frame: 12-months ]
    high sensitivity C-reactive protein (as available).

  3. Clinical and functional assessments [ Time Frame: 12-months ]
    Exercise capacity: peak aerobic power (VO2peak) and the VE/VCO2 slope



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female patients 18 years of age who are diagnosed with heart failure with reduced ejection fraction ("systolic HF") corresponding to New York Heart Association Class II-III for 3 months prior to enrolment;
  2. documentation of LVEF 40%;
  3. subject has access to a personal computer;

Exclusion Criteria:

  1. Documentation at enrolment of renal failure, significant liver disease or poorly controlled diabetes mellitus;
  2. persistent systolic or diastolic hypertension [systolic > 170 mmHg or diastolic > 100 mmHg despite antihypertensive therapy;
  3. CHF secondary to cardiovascular co-morbidities/procedures;
  4. previous heart transplant or wait listed for heart transplant at time of enrolment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864369


Locations
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Canada, British Columbia
St.Paul's Hospital- UBC
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2N2
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Sponsors and Collaborators
University Health Network, Toronto
Heart and Stroke Foundation of Ontario
Investigators
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Principal Investigator: Robert P Nolan, PhD University Health Network- University of Toronto

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Robert Nolan, Research Psychologist- Director, Behavioral Cardiology Research Unit, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01864369     History of Changes
Other Study ID Numbers: MOP 126118
First Posted: May 29, 2013    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Keywords provided by Robert Nolan, University Health Network, Toronto:
Heart Failure
e-counseling
quality of life
self-care
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases